Cleared Abbreviated

K140379 - MEGA BIG BOY CONDOM

K140379 is an FDA 510(k) clearance for MEGA BIG BOY CONDOM, manufactured by Okamoto USA, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 137-day FDA review.

K140379 · Okamoto USA, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
137d
Days
Class 2
Risk

K140379 is an FDA 510(k) clearance for the MEGA BIG BOY CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Okamoto USA, Inc. (Washington, US). The FDA issued a Cleared decision on July 1, 2014 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Okamoto USA, Inc. devices

FDA 510(k) Submission Details - K140379

510(k) Number K140379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2014
Decision Date July 01, 2014
Days to Decision 137 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 161d · This submission: 137d
Pathway characteristics
Standards-based clearance path.

HIS Device Classification - Class 2, Special Controls

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIS Condom

All 254
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K140379.
SKORE AND MULTIPLE BRANDS
K132490 · Ttk Protective Devices Limited (Formerly Ttk-Lig L · Oct 2014
NATURAL RUBBER LATEX MALE CONDOMS
K141059 · Karex Industries Sdn. Bhd. · Aug 2014
OKAMOTO STUDDED CONDOM
K141256 · Okamoto USA, Inc. · Jul 2014
SUSTAIN
K131866 · Hollender Sustainable Brands, LLC · May 2014
INSTINCT
K132390 · Profilatex, S.A. DE C.V. · Apr 2014
MALE LATEX CONDOM
K132107 · Nulatex Sdn. Bhd. · Mar 2014